Medicines manufacturers

Bureau of Labor Statistics (BLS). 2008. Career guide to industries, 2008-09 edition. Chemical manufacturing, except pharmaceutical and medicine manufacturing, www.bls.gov/oco/cg/ cgs008.htim (accessed February 16, 2008). 

Ensure that all medicines manufacturing, importation, exportation, wholesale and distribution establishments are licensed. Activities and premises must comply with Good Manufacturing Practices (GMP) and Good Distribution Practice requirements... 

Furthermore, a condition of importing generic medicines, manufactured in another country, under paragraph 6 (WTO 2003) requires that the importing country issue a compulsory license for that medicine. A compulsory license can only, in effect, be issued by a nation that grants patents on that medicine. There are two problems inherent in this. First, many of the poorest countries cannot afford a patent system and thus cannot grant pharmaceutical patents. Second, many companies do not expend... 

Until the twentieth century, cannabis was a legal product in every state. It was an accepted medication for a variety of conditions, and a frequent ingredient in patent medicines. In 1906, the Pure Food and Dmg Act forbade the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, including those containing cannabis. The law put most patent medicine manufacturers out of business. 

Generally, dietary supplement and herbal medicine manufacturers are not required to meet the same standards and regulations that apply to the pharmaceutical superpowers. 

Although herbal medicines tend to be less expensive than their FDA-labeled counterparts, the cost can still be substantial if examined over several weeks to months. Costs related to delayed effective therapy, side effects, drug interactions, and hospital admissions might also be considered in this regard. As herbal medicine becomes more popular and as herbal medicine manufacturers spend more and more on advertising, the margin of cost difference between the two types of drugs will diminish. 

Jasmina Mircheva, MD, PhD, received her medical degree from the Medical Academy in Sofia. She also has a PhD in experimental oncoimmunology. Dr. Mircheva has been the Director for Medical Affairs for Central and Eastern Europe for the European Proprietary Medicines Manufacturers Association (AESGP) in Brussels since June 1998. Previously, Dr. Mircheva had been ciffiliated with the National... 

Medicine manufacture needs a licence issued by the Minister of Health with the agreement of the Minister of the Economy. The prerequisite for the license is the GMP inspection of the NIP. Qualified persons are needed for release. According to a governmental submission to Parliament that was not discussed when the manuscript was finalized, the right of issuing MA would be delegated to the NIP. 

The evasion of formulation and toxicological testing by herbal medicine manufacturers is completely illogical in this context. For example, the Butterbur (or Bog Rhubarb Petasites hybridus) contains well-characterized carcinogens. Butterbur extract tablets are sold as chronic oral therapies... 

STP DOM). A hallucinogenic, habit-forming drug, used in medicine manufacture and use controlled by law in the U.S. 

AESGP Association Europeenne des Specialites Grand Public (Euro pean Proprietary Medicines Manufacturers Association)... 

Batch A defined quantity of raw material, product, or medicine manufactured during a given cycle of production. The essential quality of the batch is its homogeneity. In the case of continuous manufacture, the batch must correspond to a define fraction of the production of the medicine, the homogeneity of which can be guaranteed. 

WHO and other partners support local production of essential medicines, manufactured in accordance to good manufacturing practices (GMP), where this results in lower prices. This can be facilitated by voluntary licensing, transfer of technology hy the originator companies, and other suitable mechanisms [15]. It must be recognized however that local production will not always result in lower prices and it may run into considerable problems where technical experience is lacking establishment of a new production plant in a country where none existed before is a step to be undertaken only after careful consideration. 

The evasion of formulation and toxicological testing by herbal medicine manufacturers is completely illogical in this context. For example, Peta-sites hybridus (the butterbur or bog rhubarb) contains well-characterized carcinogens. Butterbur extract tables are sold as chronic oral therapies for bladder dysfunction and migraine prevention, and claimed to be innocuous on chemical purity grounds. Similarly, oral melatonin has an absolute bioavailability of about 15% maximum, and has been withdrawn in the UK and Japan due to concerns about safety (DeMuro et al 2000). 

FIGURE 2 Possible configurations for optical interconnects based on SPAs. (a) Board-to-board, where SPAs on the boards are used in place of metal conductor pins, (b) Chip-to-chip, where patterned waveguides direct light between SPAs that have been bonded to the chips. [Fig. 2a reprinted by permission of Laurin Publishing Co., from Johnson, K., and Neff, J. (1995). Improving Medicine, Manufacturing and the Military, Photonics Spectra 29(11), 80-85. 

A European Community Council Regulation (No. 315/93) defines a food contaminant as any substance not intentionally added to food which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food, or as a result of environmental contamination. Extraneous matter, such as, for example, insect fragments, animal hair, etc. is not covered by this definition. ... 

Product knowledge for aU pharmacists working directly with patients, to enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacist to remind and focus them on the application of the medicines manufactured. 

As part of the REMS, health-care professionals who prescribe rosiglitazone medicines will be required to have training about the current state of knowledge concerning the cardiovascular risk of rosiglitazone medicines. Manufacturers will also send Dear Healthcare Provider and Dear Professional Society letters to educate prescribers about the new information. 

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